Preclinical Project Manager, Medical Device

About the Company: vVARDIS is a Swiss-based oral health company founded by Dr. Haley and Dr. Goly Abivardi, dentists, innovators, and award-winning entrepreneurs. vVARDIS is the result of a combined 30 years of dental and entrepreneurial experience, and 20 years of laboratory and clinical research paired with the creative vision of its founders.At vVARDIS, we are committed to delivering innovative solutions that enhance oral health and well-being, inspired by the vision of our founders to foster preventive rather than reparative dentistry.Scientifically proven in over 200 publications, our unique technology can treat early caries, offering a noninvasive, pain-free solution for patients of all ages. We offer a number of oral health products targeting dental professionals and their patients, as well as consumers, all based on our proprietary technology.We value our people and believe in fostering a positive and collaborative work environment, based on our core values of innovation, excellence, integrity, and empathy.We are located in Zug, Switzerland, with operations in Europe and the U.S. Join us on this exciting journey!Position Overview:As a Preclinical Project Manager, you will lead and coordinate preclinical research activities supporting the development of vVARDIS dental and oral care medical devices. You will ensure studies are executed in compliance with regulatory standards (e.g., ISO 10993, FDA, MDR), and collaborate with internal teams and external partners to drive product development forward.Key Responsibilities:Project ManagementCoordinate in vitro and in vivo studies for safety, efficacy, and biocompatibility.Regulatory & Quality ComplianceEnsure all preclinical activities comply with GLP, ISO 13485, ISO 10993, and FDA/MDR guidelines.Support documentation for regulatory submissions (e.g., 510(k), CE marking).Cross-functional CollaborationWork closely with Regulatory Affairs and Quality Assurance, Marketing and Scientific Affairs, and external CROs.Serve as the primary point of contact for study-related communications.Documentation & ReportingReview study protocols, reports, and summaries for internal and external stakeholders.Maintain accurate records to support audits and inspections.Vendor ManagementIdentify and manage CROs and lab partners for outsourced testing.Negotiate contracts and ensure timely delivery of high-quality data.Qualifications & Skills:Bachelor’s or Master’s degree in biomedical sciences, toxicology, or related field.3–5 years of experience in preclinical research or project management in the medical device sector.Strong knowledge of biocompatibility testing, ISO standards, and regulatory pathways.Excellent organizational and communication skills.Experience with dental or oral care devices is a plus.Familiarity with dental biomaterials and oral microbiology.Experience with EU MDR and FDA regulatory submissions.Proficiency in tools like Microsoft Project, Excel, and GraphPad Prism.Your Personality You’re energized by being part of a growing team and contributing to the build-up of a business. You thrive in dynamic environments and embrace change with a continuous improvement mindset. You bring a strong mix of analytical thinking, project management, and attention to detail—paired with the flexibility to handle both routine tasks and complex challenges. You’re a proactive doer who enjoys variety, takes ownership, and works independently while keeping the broader business goals in focus. In our lean and agile organization, self-sufficiency and initiative are key. You embody high ethical standards, learn quickly, and consistently strive for excellence in execution—with humility and a collaborative spirit.vVARDIS is an equal opportunities employer and welcomes applications from all suitably qualified persons.Join vVARDIS: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about vVARDIS and our career opportunities, join the vVARDIS Network on LinkedIn: https://www.linkedin.com/company/vvardis/mycompany/If you don’t hear from us, please know that we highly value your interest in vVARDIS and encourage you to stay connected for future opportunities.